| CTRI Number |
CTRI/2019/02/017746 [Registered on: 20/02/2019] Trial Registered Prospectively |
| Last Modified On: |
23/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the effects of a nerve block in reducing pain following kidney stone operation |
|
Scientific Title of Study
|
The effects of Erector Spinae Plane (ESP) block on post-operative pain management in Percutaneous Nephrolithotomy (PCNL) – a randomized controlled clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Satyaki Sarkar |
| Designation |
Junior Resident (Academic), Department of Anaesthesiology |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Bhubaneswar |
| Address |
Room No : 218, PG III,
AIIMS Bhubaneswar,
Sijua, Patrapara, Bhubaneswar.
Khordha
ORISSA
751019
India |
| Phone |
9883804819 |
| Fax |
|
| Email |
dsatyakisarkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayanta Kumar Mitra |
| Designation |
Associate Professor, Department of Anaesthesiology, AIIMS Bhubaneswar |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Bhubaneswar |
| Address |
Department of Anaesthesiology,
All India Institute of Medical Sciences(AIIMS), Bhubaneswar,
Sijua, Patrapara.
Khordha
ORISSA
751019
India |
| Phone |
9438884043 |
| Fax |
|
| Email |
mitra.jayanta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satyaki Sarkar |
| Designation |
Junior Resident (Academic), Department of Anaesthesiology |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Bhubaneswar |
| Address |
Room No : 218, PG III,
AIIMS Bhubaneswar,
Sijua, Patrapara, Bhubaneswar.
Khordha
ORISSA
751019
India |
| Phone |
9883804819 |
| Fax |
|
| Email |
dsatyakisarkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences (AIIMS, Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences AIIMS Bhubaneswar |
| Address |
Sijua, Patrapara, Bhubaneswar
Orissa, India - 751019 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Satyaki Sarkar |
All India Institute of Medical Sciences (AIIMS) Bhubaneswar |
Department of Anaesthesiology,
AIIMS Bhubaneswar,
Sijua, Patrapara,
Bhubaneswar
Khordha
ORISSA |
9883804819
dsatyakisarkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector Spinae Plane (ESP) block |
Performed at the L1 vertebral level under ultrasound guidance with Inj. Bupivacaine (0.25%) 20ml, before the start of the surgery after the induction of general anaesthesia |
| Comparator Agent |
Placebo-control |
A sham procedure similar to the ESP block will be performed at the L1 vertebral level under ultrasound guidance with Inj. 0.9% Normal saline 20ml, before the start of surgery after the induction of general anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients (Age >18 years and <60 years) with ASA I to II functional status undergoing PCNL under the Department of Urology in AIIMS, Bhubaneswar.
2. Patients who can understand and provide a valid consent for the procedure and also can understand and are willing to report the pain using VAS score.
|
|
| ExclusionCriteria |
| Details |
1. Patients who are currently suffering from chronic pain syndromes and are already under treatment with daily analgesics.
2. Patients in whom multiple nephrostomy tracts have been used, bilateral PCNL is undertaken or in whom conversion of the procedure to open surgery or extension of the normal procedure is required (e.g. second look nephrostomy).
3. Patients in whom the anatomy of the anaesthetic injection site is not clearly delineable on ultrasound examination due to any reason.
4. Patients who remain intubated/ sedated in the SICU post procedure and cannot participate in reporting the VAS score. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To compare the total dose (in mg) of Injection Tramadol required to achieve adequate analgesia (VAS score less than 5) in the total period of 24 hrs post PCNL in the patients receiving ESP block and in the control group. |
At the end of 24hrs post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To compare the Visual Analog Scale (VAS) score and the Dynamic Visual Analog Scale (DVAS) score at 2 hrs, 12 hrs and 24 hrs post PCNL in patients receiving ESP block and in the control group. |
2hrs, 12hrs and 24hrs post surgery |
| 2. To compare the time to the first demand of rescue analgesia (VAS score ≥ 5) using Inj. Tramadol (an opioid analgesic) post-recovery from general anaesthesia after PCNL in the patients receiving ESP block and in the control group. |
Single time point, varies across the study participants, data collected at the end of 24hrs |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
28/02/2019 |
| Date of Study Completion (India) |
31/08/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A prospective, randomized, placebo-controlled, double-blinded clinical trial to evaluate the efficacy of ipsilateral Erector Spinae Plane block (ESP block) with 20ml 0.25% Inj. Bupivacaine at the L1 vertebral level under ultrasound guidance, performed under general anaesthesia in a prone position before the start of surgery in adult patients undergoing Percutaneous Nephrolithotomy (PCNL) in a tertiary care hospital in India. The placebo control will be injection of 20 ml of Inj. Normal saline (0.9%) instead of Inj. Bupivacaine using an identical procedure. The study will recruit 40 patients over a period of 18 months. The primary outcome variable will be the total dose of intravenous Inj. Tramadol required to maintain adequate analgesia (VAS score less than 5). The secondary outcome variables are the time to first demand of rescue analgesia (VAS score greater than 5); and post operative pain as measured by the Visual Analog Scale (VAS) score and Dynamic Visual Analog Scale (DVAS) score and evaluated at 2hrs, 12hrs and 24hours post surgery. |